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Multi-Omics Study of the Effect and Mechanisms of Acupuncture on Psychoneurological Symptoms Among Breast Cancer Survivors

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ClinicalTrials.gov Identifier: NCT05417451
Recruitment Status : Recruiting
First Posted : June 14, 2022
Last Update Posted : September 15, 2023
Sponsor:
Information provided by (Responsible Party):
Hongjin Li, University of Illinois at Chicago

Study Description
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Brief Summary:
The objectives of this study to explore whether acupuncture can improve the psychoneurological symptom cluster (pain, fatigue, sleep disturbance) in survivors of breast cancer and explore biomarker changes after the acupuncture intervention. Acupuncture treatments will be provided to breast cancer survivors twice weekly for 5 weeks.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: Acupuncture Not Applicable

Detailed Description:
The investigators will conduct the study with early stage breast cancer survivors who have completed their primary cancer treatment. They will all receive acupuncture. Treatments will be twice weekly for 5 weeks, for 30 minutes per treatment. At baseline and post-treatment, subjects will be collected blood and stool samples, complete symptom questionnaires that measure pain, fatigue, and sleep disturbance.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Multi-Omics Study of the Effect and Mechanisms of Acupuncture on Psychoneurological Symptoms Among Breast Cancer Survivors
Actual Study Start Date : November 1, 2021
Estimated Primary Completion Date : May 31, 2025
Estimated Study Completion Date : May 31, 2025

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Acupuncture
All subjects will receive active acupuncture. The acupuncture intervention will consist of 10 acupuncture sessions, twice weekly for 5 weeks. There will be at least 1 day in between session.
 Other: Acupuncture
All participants will receive a semi-standardized acupuncture protocol (standardized points for pain, fatigue, depression, anxiety, sleep disturbance, with additional points for patient's particular pain location)


Outcome Measures
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Primary Outcome Measures :
  1. PROMIS Pain Interference [ Time Frame: After 10th acupuncture treatment, at 6 weeks post-baseline (study completion) ]
    Scores range from 4-20; higher scores indicate that pain is interfering with daily activities more

  2. PROMIS Fatigue [ Time Frame: After 10th acupuncture treatment, at 6 weeks post-baseline (study completion) ]
    Scores range from 4-20; higher scores indicate that severe fatigue

  3. PROMIS Sleep Disturbance [ Time Frame: After 10th acupuncture treatment, at 6 weeks post-baseline (study completion) ]
    Scores range from 4-20; higher scores indicate that severe sleep disturbance


Secondary Outcome Measures :
  1. PROMIS Depression [ Time Frame: After 10th acupuncture treatment, at 6 weeks post-baseline (study completion) ]
    Scores range from 4-20; higher scores indicate that severe depression

  2. PROMIS Anxiety [ Time Frame: After 10th acupuncture treatment, at 6 weeks post-baseline (study completion) ]
    Scores range from 4-20; higher scores indicate that severe anxiety


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women with histologically confirmed stage 0, I, II, or III breast cancer
  • who have completed their primary cancer treatment (e.g., surgery, radiotherapy, chemotherapy) at least 3 months prior and within 5 years
  • are currently receiving adjuvant endocrine therapy
  • are able to read and speak English
  • with self-reported pain, fatigue, sleep disturbance in the last three months and their "worst" severity rating ≥ 3 (0-10 numeric rating scale) for at least two of the three symptoms

Exclusion Criteria:

  • have self-reported hospitalization for psychiatric illness within the past 2 years
  • have a bleeding disorder
  • physically or cognitively unable to complete the study procedures
  • pregnant women
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05417451


Contacts
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Contact: Hongjin Li, PhD 312-413-9845 hongjin@uic.edu

Locations
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United States, Illinois
University of Illinois at Chicago College of Nursing Recruiting
Chicago, Illinois, United States, 60612
Contact: Hongjin Li       hongjin@uic.edu   
Sponsors and Collaborators
University of Illinois at Chicago
More Information
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Responsible Party: Hongjin Li, Assistant Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT05417451    
Other Study ID Numbers: 2021-0840
First Posted: June 14, 2022    Key Record Dates
Last Update Posted: September 15, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases